Quantitative laser diffraction method for the assessment of protein subvisible particles

Totoki, Shinichiro; Yamamoto, Gaku; Tsumoto, Kouhei et al.

Journal of Pharmaceutical Sciences, 2015, 104(2), 618-626

アクセス数:555件（2025-07-27 09:28 集計）

固定URL: https://hdl.handle.net/11094/79033

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タイトル
Quantitative laser diffraction method for the assessment of protein subvisible particles
著者
著者名
Totoki, Shinichiro
著者名
Yamamoto, Gaku
NRID
1000090271866 1000090271866
著者名
Tsumoto, Kouhei
NRID
1000090335381 1000090335381
ORCID
0000-0002-5181-179X 0000-0002-5181-179X
researchmap permalink
read0090387 read0090387
Scopus Author ID
35429790100 35429790100
著者名
Uchiyama, Susumu
NRID
1000000311770 1000000311770
researchmap permalink
read0068600 read0068600
著者名
Fukui, Kiichi
キーワード等
laser diffraction method
proteins
protein aggregation
biopharmaceutical characterization
subvisible particles
imaging methods
particle size
内容
Shinichiro Totoki, Gaku Yamamoto, Kouhei Tsumoto, Susumu Uchiyama, Kiichi Fukui. Quantitative Laser Diffraction Method for the Assessment of Protein Subvisible Particles. Journal of Pharmaceutical Sciences, Volume 104, Issue 2, 2015, Pages 618-626. https://doi.org/10.1002/jps.24288.
抄録
Laser diffraction (LD) has been recognized as a method for estimating particle size distribution. Here, a recently developed quantitative LD (qLD) system, which is an LD method with extensive deconvolution analysis, was employed for the quantitative assessment of protein particles sizes, especially aimed at the quantification of 0.2-10 μm diameter subvisible particles (SVPs). The qLD accurately estimated concentration distributions for silica beads with diameters ranging from 0.2 to 10 μm that have refractive indices similar to that of protein particles. The linearity of concentration for micrometer-diameter silica beads was confirmed in the presence of a fixed concentration of submicrometer diameter beads. Similarly, submicrometer-diameter silica beads could be quantified in the presence of micrometer-diameter beads. Subsequently, stir- and heat-stressed intravenous immunoglobulins were evaluated by using the qLD, in which the refractive index of protein particles that was determined experimentally was used in the deconvolution analysis. The results showed that the concentration distributions of protein particles in SVP size range differ for the two stresses. The number concentration of the protein particles estimated using the qLD agreed well with that obtained using flow microscopy. This work demonstrates that qLD can be used for quantitative estimation of protein aggregates in SVP size range.
出版者
Elsevier
収録物名
Journal of Pharmaceutical Sciences
巻(号)
104(2)
ページ
618-626
刊行年月
2015-01-01
言語
英語
ハンドルURL
https://hdl.handle.net/11094/79033
PISSN
00223549
eISSN
15206017
NCID
AA00704450
関連情報 (isIdenticalTo)
DOI (出版社版)
https://doi.org/10.1002/jps.24288
PMID
25449441
アクセス権
open access
権利情報
© 2014 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association. Published by Elsevier Inc. This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
出版タイプ
Version of Record
カテゴリ
学術雑誌論文 Journal Article